Conventional medical therapies are typically associated with certain risks and benefits for patients. In many instances, these risks and benefits may be managed by effective counseling between a prescribing physician and patient, based on information provided by the product's labeling and other available information.
Medical therapies that pose risks that require additional patient compliance or monitoring, however, may not be as effectively managed by the prescribing physician and patient. Indeed, in some instances, these medical therapies may only be distributed, or the patient provided access to these medical therapies, according to additional requirements described in the product's labeling or as a condition for product marketing. In addition, a patient's risk level may change over time, requiring a reassessment of the appropriate risk management program, including programs with little or no restrictions. Conventional distribution methods typically rely on the prescribing physician or dispensing pharmacist to read and follow these labeling requirements. In some instances, a regulatory authority, such as, the U.S. Food and Drug Administration (FDA), has required the development of a restricted distribution or access program prior to market approval for the medical therapy. Conventional restricted distribution or access programs typically required that physicians, patients, pharmacies, or wholesalers be pre-registered prior to prescribing or dispensing medical therapies. Other conventional distribution programs required that patients be assigned to certain risk categories before generating prescription validation codes in a computer readable medium, or that prescriptions be dispensed only after verifying the prescription validation codes in a computer readable medium. In some instances, these validation codes were generated following the assignment of patients to certain risk groups and certain requirements being met by a patient assigned to the group, including diagnostic testing.
In yet other instances, patient data may be entered into a computer database before distributing the medical therapy with steps requiring a confirmation that the prescriber has the ability to prescribe and certain patient educational materials have been read and generation of periodic reports regarding the distribution of the medical therapy via the computer database.
One example of a conventional restricted access program is the program approved as part of the labeling for Clozaril® (clozapine) that requires pharmacies to be pre-registered to dispense the drug only to patients for whom baseline and periodic white blood cell counts have been taken. This system requires the pharmacist to monitor compliance with the requirements of the restricted drug access program approved as part of the approved labeling for the drug product.
Another example of a conventional restricted access program is the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®), which was approved as part of the labeling for Thalomid® (thalidomide) and requires, among other things, that physicians, patients, and pharmacies be pre-registered in a computer readable medium and the generation of a prescription code following the necessary registrations and an interactive voice response system survey. This code must be entered on the registered patient's prescription by a registered prescriber and later verified by a registered pharmacist prior to dispensing the drug. Another example is the restricted distribution program, Tracleer Access Program (T.A.P.), which was approved as part of the labeling for Tracleer® (bosentan).
One example of a system for delivering medical therapy is described in U.S. Pat. No. 6,561,976, issued to Elsayed et al., entitled, “Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Fetus or Other Contraindicated Individual to the Drug.” This relates to a method for delivering a teratogenic drug a patient while preventing fetal exposure to the drug. This method involves registering, in a computer readable storage medium, physicians permitted to prescribe the drug, and registering the patient, in a computer readable medium, including the patient's ability to become pregnant or impregnate a female. Following these and other steps, the patient is provided access to the drug only after “verifying” that the patient is either incapable of becoming pregnant or is not currently pregnant by consulting one or more databases.
Another example is provided in U.S. Pat. No. 6,869,399, issued to Williams et al., entitled, “Methods for Delivering a Drug to a Patient While Restricting Access to the Drug By Patients for Whom the Drug May be Contraindicated.” This relates to a method for permitting prescriptions to the teratogenic drug thalidomide only after a pharmacy has become aware of approval of a prescription for thalidomide for the patient from a computer readable storage medium. The prescription approval in the computer readable storage medium is generated after assigning the patient to a risk group and then determining that the risk from administering the drug is acceptable.
Yet another example is provided in U.S. Patent Pub. No. US 2005/0215869, by Elsayed et al. entitled “Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug.” This relates to a method for delivering a drug to a patient while preventing the exposure of a fetus or other contraindicated individuals to the drug. This method involves receiving information from a prescriber including information about the prescriber, patient, and medical therapy and entering the data in a computer database prior to distributing the drug. Prior to distributing the drug, a confirmation is made that a prescriber has the ability to prescribe the drug and patient educational materials have been read. Periodic reports are generated regarding the distribution of the drug via the computer database.